Author: Pär Tellner, Member of ICH Management Committee (ICH MC), EFPIA * Date: 27/08/2018 *

Trends in the development of regulatory systems by the

example of ICH countries

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GMP conference, Kazan, Russia

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Overview of ICH

Trends in development of reg systems by example of ICHcountries

Challenges and opportunities for ICH

Overview of Presentation

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Overview of ICH

The ICH Association is now known as the “InternationalCouncil for Harmonization of Technical Requirements forPharmaceuticals for Human Use (ICH).”

Unique harmonisation initiative for regulators andpharmaceutical industry

Originally founded in 1990

Reformed as a non-profit legal entity under Swiss Law onOctober 23, 2015

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Overview of ICH

ICH Successes

GCP (Good Clinical Practice)

Clinical trials conducted in one ICH region can be utilised inother ICH regions by setting the common standards onscience and ethics.

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Overview of ICH

ICH Successes

CTD/eCTD (Common Technical Document)

CTD brings together all Quality, Safety and Efficacy information in a common, harmonised format, accepted by regulators in all ICH regions. It has revolutionised regulatory review processes for regulators and industry

CTD

eCTDReview

ICH

Guidelines

Review

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Overview of ICH

ICH Successes

MedDRA (Medical Dictionary for Regulatory Activities)

Highly specific, standardised medical terminology developed by ICH tofacilitate sharing of regulatory information

It is used for registration, documentation and safety monitoring ofmedical products both before and after marketing authorisation

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Overview of ICH

Structure of the ICH Association

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Overview of ICH

ICH Members 27 August 2018

Members:

Founding Regulatory Authorities: EC/EMA, MHLW/PMDA, FDA

Founding Industry Associations: EFPIA, JPMA, PhRMA

Standing Regulatory Authorities: Swissmedic, Health Canada

Industry Associations: IGBA (Generics), WSMI (OTC) and BIO (Biotech)

Regulatory Authorities: MFDS (South Korea), ANVISA (Brazil), NMPA(previous name CFDA, China), HSA, (Singapore) and TFDA (ChineseTaipei)

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Overview of ICH

ICH Observers 27 August 2018

Standing Observers: WHO, IFPMA

Observers:

Regional harmonisation initiatives (RHIs): APEC, ASEAN, EAC, GCC, PANDRA and SADC

Regulatory authorities from Russia, Australia, Chinese Taipei, India, Mexico, Singapore, South Africa, Cuba, Kazakhstan, Columbia, Turkey, Malaysia, Armenia and Moldavia

International pharmaceutical industry organisations: APIC

International organisations: IPEC, CIOMS, EDQM, USP, PIC/S andBill & Melinda Gates Foundation

Ad-hoc observers: Upon invitation

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Overview of ICH

New topics

At the June 2018 meeting in Kobe, Japan, ICH decided to initiate threenew topics for harmonisation:

Q13: Continuous manufacturing

Q14/Q2(R2): Analytical Procedure Development and Revision ofQ2(R1) Analytical Validation

M11: Clinical electronic Structured Harmonised Protocol (CeSHarP)

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Trends in the development of reg. systems

– DRAs implement ICH guidelines

During the last 2 years the following Drug Regulatory Authorities (DRAs)have become members of ICH:

MFDS (South Korea), ANVISA (Brazil), NMPA (previous name CFDA,China), HSA, (Singapore) and TFDA (Chinese Taipei)

These DRAs have therefore committed themselves to implement all ICHguidelines within a period of 5 years. Several DRAs e g NMPA, China isinvesting huge resources in training of assessors in ICH guidelines. EFPIAexperts have contributed as speakers in these training courses.

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Trends in the development of reg. systems - GMP mutual

regognition agreements (MRA) by EU and other countries

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Challenges and Opportunities for ICH*

Challenges:Keep up the efficiency in the work to develop ICH guidelines, when

you get more members and observersKeep ICH as a scientific association with regulatory authorities and

industry associations as membersChallenge for experts to manage all request for training in

implementation of ICH guidelines from new members

Opportunities:By opening up ICH for new members, Drug Regulatory Authorities in

emerging markets will influence and implement the ICH guidelines.Guidelines will therefore be harmonised worldwide, which will speedup patients´ access to new medicinal products. It will also facilitateboth for domestic and multinational companies to export theirproducts.ICH will therefore also be relevant for the future, when production and

R&D are moving out from Europe and the US

* My views

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Summary

Examples of ICH Successes are Good Clinical Practice, Common TechnicalDocument and MedDRA (Medical Dictionary for Regulatory Activities)

More and more DRAs become members of ICH and implement ICHguidelines. ICH has therefore become the de facto global standard.

EU has taken the lead to make GMP mutual recognition agreementswith other countries. Thus import testing and GMP inspections aremutually recognised. Membership of PIC/S (Pharmaceutical InspectionCo-operation Scheme) facilitate such agreements. (PIC/S leads theinternational development, implementation and maintenance ofharmonised GMP standards and quality systems of Inspectorates.)

Author: Pär Tellner, Pharmacist, Member of ICH Management Committee (MC), EFPIA *

BACKUP

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Overview of ICH

Purpose

Promotion of public health through internationalharmonisation that contributes to:

Prevention of unnecessary duplication of clinical trial andpost market clinical evaluations

Development and manufacturing of new medicines

Registration and supervision of new medicines

Reduction of unnecessary animal testing withoutcompromising safety and effectiveness

Accomplished through Technical Guidelines that are implemented by regulatory authorities.

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Steps in the ICH Process for

Guideline Development

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Step 1:

WG works to prepare a consensus draft of the technical

document.

Step2:

Step 2a:

The Assembly is invited to endorse the technical document.

Step 2b:

The ICH Regulatory Members of the Assembly are invited to

endorse the draft Guideline.

The ICH Step Process (1)

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Step 3:

Public consultation by the ICH Regulatory Members and ICH

Secretariat. All comments are considered by the WG.

Step 3 is finalised once concensus is reached in the WG.

Step 4:

The Regulatory Members of the Assembly adopt the

final document.

Step 5:

Implementation by the ICH Regulatory Members.

The ICH Step Process (2)

Thank you!

E-mail: par.tellner@efpia.eu

For more info on ICH please seewww.ich.org

EFPIA Brussels OfficeLeopold Plaza Building * Rue du Trône 108

B-1050 Brussels * BelgiumTel: + 32 (0)2 626 25 55

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